BD FACSCANTO¿ II

Additional Manufacturer Narrative

THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: G.1 - REPORTING OFFICE CONTACT - (B)(4). G.1 - MANUFACTURING SITE CONTACT - (B)(4). G.1 - REPORTING OFFICE- BECTON DICKINSON AND COMPANY BD BIOSCIENCES. H6. INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE BLUE LASER CURRENT HIGH ERROR WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: REVIEW OF THE COMPLAINT TREND, DEFECT TREND, DHR REVIEW, RISK ANALYSIS, AND SERVICE ACTIVITY. THE POTENTIAL CAUSE OF THE ISSUE WAS DETERMINED TO BE INCORRECT REFERENCE VALUE OF CURRENT FOR BLUE LASER. THE SUPPORT ENGINEER PROVIDED TROUBLESHOOTING INSTRUCTIONS REGARDING ADJUSTMENT TO REFERENCE VALUE OF BLUE LASER CURRENT AND THIS RESOLVED THE ISSUE AND THE INSTRUMENT IS FUNCTIONING AS EXPECTED. CLEANING AND REGULAR MAINTENANCE IS ESSENTIAL FOR KEEPING THE INSTRUMENT AT ITS OPTIMAL PERFORMANCE. THIS INFORMATION CAN BE FOUND IN THE BD FACSCANTO¿ II FLOW CYTOMETER INSTRUCTIONS FOR USE (IFU) MANUAL, #23-20269-00 REV. 1/VERS. A, STARTING ON PAGE 150. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H.10.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH THE BD FACSCANTO¿ II ERROR MESSAGES WERE BYPASSED AND USER COULD PROCEED WITH TESTING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ERROR MESSAGE CHECKLIST: 1. ARE YOU RUNNING PATIENT SAMPLES FOR DIAGNOSTIC TEST? UNKNOWN. 2. WAS THERE AN ERROR MESSAGE? YES. 3. DID THE CUSTOMER BYPASS THE ERROR MESSAGE? YES. 4. IS THIS PRESTO? NO. I CALLED THE CUSTOMER BACK AND HAD HIM LOG IN AS SERVICE. WE LOOKED AT THE LASER TAB AND THE BLUE LASER CURRENT. THE CURRENT MEASURED WAS 1.84 AND THE REFERENCE WAS 1.54. I HAD HIM CHANGE THE REFERENCE VALUE TO 1.84. HE LOGGED OUT AND SAVED THE THE VALUE. RAN A TUBE OF WATER JUST TO SEE IF THE ERROR POPPED UP AND IT DID NOT. I HAD THE CUSTOMER LOOK AT THE LAST KNOWN GOOD PERFORMANCE CHECK FOR THE CURRENT RANGE. WITH FSC TRIGGER THE CURRENT RANGE IS 1.23 TO 1.85. I INFORMED THE CUSTOMER THEY WERE AT THE HIGH END OF THE RANGE. I INFORMED HIM THAT IF THE ERROR OCCURS AGAIN, MOST LIKELY THERE WILL BE AN ISSUE WITH THE LASER. CUSTOMER IS ACCEPTING. SYSTEM IS WORKING PROPERLY. CUSTOMER IS SATISFIED. CASE IS COMPLETE. THE ERROR HAS BEEN OCCURRING OVER THE LAST 2 WEEKS MORE FREQUENTLY. I WAS ASKING THE CUSTOMER IF THE COMPUTER HAD INTERNET ACCESS AND HE SAID NO. THEY RUN WIN7. I WAS PREPARED TO GO IN TO FSE SERVICE MODE WHERE THE CUSTOMER WOULD GO IN, BUT HE INFORMED ME THE UNIT WAS BEING OPERATED AND HE DID NOT HAVE ACCESS.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH THE BD FACSCANTO¿ II ERROR MESSAGES WERE BYPASSED AND USER COULD PROCEED WITH TESTING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ERROR MESSAGE CHECKLIST: 1. ARE YOU RUNNING PATIENT SAMPLES FOR DIAGNOSTIC TEST? UNKNOWN. 2. WAS THERE AN ERROR MESSAGE? YES. 3. DID THE CUSTOMER BYPASS THE ERROR MESSAGE? YES. 4. IS THIS PRESTO? NO. I CALLED THE CUSTOMER BACK AND HAD HIM LOG IN AS SERVICE. WE LOOKED AT THE LASER TAB AND THE BLUE LASER CURRENT. THE CURRENT MEASURED WAS 1.84 AND THE REFERENCE WAS 1.54. I HAD HIM CHANGE THE REFERENCE VALUE TO 1.84. HE LOGGED OUT AND SAVED THE VALUE. RAN A TUBE OF WATER JUST TO SEE IF THE ERROR POPPED UP AND IT DID NOT. I HAD THE CUSTOMER LOOK AT THE LAST KNOWN GOOD PERFORMANCE CHECK FOR THE CURRENT RANGE. WITH FSC TRIGGER THE CURRENT RANGE IS 1.23 TO 1.85. I INFORMED THE CUSTOMER THEY WERE AT THE HIGH END OF THE RANGE. I INFORMED HIM THAT IF THE ERROR OCCURS AGAIN, MOST LIKELY THERE WILL BE AN ISSUE WITH THE LASER. CUSTOMER IS ACCEPTING. SYSTEM IS WORKING PROPERLY. CUSTOMER IS SATISFIED. CASE IS COMPLETE. THE ERROR HAS BEEN OCCURRING OVER THE LAST 2 WEEKS MORE FREQUENTLY. I WAS ASKING THE CUSTOMER IF THE COMPUTER HAD INTERNET ACCESS AND HE SAID NO. THEY RUN WINDOWS 7. I WAS PREPARED TO GO IN TO FSE SERVICE MODE WHERE THE CUSTOMER WOULD GO IN, BUT HE INFORMED ME THE UNIT WAS BEING OPERATED AND HE DID NOT HAVE ACCESS.

Additional Manufacturer Narrative

B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D.4. MEDICAL DEVICE EXPIRATION DATE: NA. E.1. INITIAL REPORTER ADDRESS 1: (B)(6). H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.